The need for urgent solutions to the global COVID-19 pandemic has led the Food and Drug Administration (FDA) to speed the arrival of several diagnostic tests for the virus to the market. While it typically takes several months before the FDA will allow a medical device or test to be sold in the United States, there are times when an urgent need for a product overwhelms the need for a slow and cautious approval. The COVID-19 pandemic is a perfect example of such a time.
Emergency Use Authorization
The FDA can speed these tests to market under what is known as Emergency Use Authorization (EUA) authority. EUA authority allows the FDA to exercise discretion and serve a public need, without the FDA fully approving a product. An EUA allows unapproved medical products or unapproved uses of approved medical products to be used in an emergency for diagnosing, treating, or preventing serious or life-threatening diseases or conditions, especially when there are no adequate approved and available alternatives.
The FDA is allowed to issue an EUA under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Under the Act, the FDA Commissioner may allow unapproved medical products or unapproved uses of approved products in response to Chemical, Biological, Radiological, and Nuclear (CBRN) threat agents, in situations when there are no adequate, approved, and available alternatives.
Three factors determine whether an EUA will be considered: the case should be an emergency; the condition or disease for which the test or treatment is being developed should be life-threatening; and no approved or adequate alternative is currently available. Before the FDA issues an EUA, the Secretary of Health and Human Services must declare that circumstances exist to justify the authorization.
EUA is Not the Same as Approval
Though EUA may seem like the same thing as FDA approval, and the difference between an approval and an EUA may seem like semantics, EUAs and full approvals are quite different. The biggest difference between full FDA approval and Emergency Use Authorization is that EUA authorization will only be in effect for as long as the public health emergency lasts.
For example, before the FDA agrees to approve a product, it must determine that there is ‘substantial evidence', after thorough and well-controlled investigations, that the drug is safe and effective. However, to approve an EUA, the FDA needs only to conclude that it is reasonable to believe that the product may be effective. The EUA standard is a much lower standard than the typical approval standard.
To be clear, the FDA isn't throwing the gates open and issuing EUAs without concern, questioning, testing, or oversight. There is still a process and there's still review and regulation. But the type of review that the FDA conducts for an EUA is not as complete nor as thorough as the type of review conducted before granting a product full FDA approval.
Indeed, the FDA requires the difference to be clear, even in the labeling. The COVID-19 tests that received EUA are required to be labeled with verbiage such as, “This home collection kit has not been FDA cleared or approved.”
Most importantly for manufacturers seeking EUAs, they must pursue full FDA approval, even while the EUA is in effect. Even though the EUA makes it legal for the manufacturer to market the product now, if and when the pandemic or other emergency ends, the EUA approval will likely end. When that happens, it will not be legal for the manufacturer to continue selling that product in the U.S. unless the product has full FDA approval.